Medical Device Testing and Validation Regulatory Compliance Training - Live Webinars, Recordings & CDs

This webinar will provide participants with key knowledge of medical device design controls by analyzing FDA 483 observations and learning what the agency is looking for with respect to each design control element.

This webinar on 3D printing will cover FDA's expectations regarding the design, manufacture, testing and approval of 3D printed medical devices.

This training program will analyze the general considerations for cGMP compliance and review the cGMP requirements in 21 CFR 4.4(b). The program will also discuss applications of cGMP requirements for specific types of combination products.

The parallel requirements for medical devices and pharmaceuticals are incorporated into this comprehensive webinar that delineates the foundation for technology transfer and validation, encompassing regulatory requirements and voluntary guidance.

This webinar will explain how to implement an effective and FDA compliant GMP training program. It will discuss regulatory requirements and expectations for a well-trained workforce.

The training program will prepare attendees to better understand the revisions to this standard as they read its requirements in detail. For those organizations that have a QMS that's compliant with ISO 13485:2003, you will benefit from this program as it will help you assess your preparations.

Attendees will come away from the training program with the tools they need to understand the various types of enclosures and how to select the correct type of enclosure for their process in order to meet regulations, protect the product, and ensure worker safety. The course is apt for personnel in FDA regulated industries who want to learn about what enclosure is best suited for their process and why.

This Sterilization validation training will review the general requirements for validation as described in ISO 11137:2006.

In this Cleaning validation training we will discuss preparing the cleaning validation protocol. Important aspects such as how to set acceptance criteria and how to measure cleanliness will then be reviewed.

This ASTM E2500 training will review how these ASTM (American Society for Testing and Materials) and ICH (International Conference on Harmonization) approaches can simplify the qualification process. Regulatory groups have responded by providing guidance documents such as ICH Q9: “Quality Risk Management” which encourages a level of risk appropriate to safety and efficacy and provides a toolbox of risk management methods. ICH Q8: “Pharmaceutical Development” encourages the use of scientific methods to mitigate risk through concepts such as Design Space, Quality by Design (QbD), Process Analytical Technology (PAT) and Continuous Verification.

This Medical Device training will describe the information needed to write such protocols, and the basic contents of those protocols. This webinar will provide valuable assistance to all regulated companies that need to validate their manufacturing processes.

This Medical device training will explain the regulatory requirements including cleaning and sterilization methods & validations.

This training will focus on the regulatory requirements for a Corrective and Preventive Actions (CAPA) system. Attendees will learn how to develop an effective CAPA system.

This webinar will discuss the common deficiencies in relation to compliance and validation issues that typically found with pharmaceutical Quality Control labs.